# K233849: BTL-499

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Apr 23, 2024 after 140 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K943450 (1995). 311 ancestors in all.
No later device cites it as a predicate yet.
0 of 312 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230467: BTL-899F, BTL Industries, Inc. (2023) Summary page 5.
- K222556: BTL-785X, BTL Industries, Inc. (2023) Summary page 5.

## Indications for use
BTL-499 is indicated to be used for: Non-invasive lipolysis (breakdown of fat) of the abdomen. Reduction in circumference of the abdomen. Non-invasive lipolysis (breakdown of fat) of the thighs. Reduction in circumference of the thighs. BTL-499 is intended for use with skin types I - VI. Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I - IV. Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under. The BTL-499 is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-499 massage function is intended to provide a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K233849
Methodology: https://510kreport.com/methodology